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Clinical Trials/NCT05618015
NCT05618015
Completed
Not Applicable

Comparison of the Effectiveness of Supervised and Home-Based Progressive Resistant Training in the Mid-Term Postoperative Period in Female Total Knee Arthroplasty Patients

Pamukkale University1 site in 1 country32 target enrollmentJuly 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Pamukkale University
Enrollment
32
Locations
1
Primary Endpoint
40m fast-paced walk test
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Early postoperative rehabilitation programs after TKA aims to provide optimal functional recovery. The current rehabilitation process in TKA typically includes 2 to 3 months post-surgery, as the greatest declines in strength and functional performance occur immediately after surgery. Yet, the content, duration, and intensity of the rehabilitation programs for the reorganization of physical function after surgery have not yet been fully clarified. Whether home-based rehabilitation is comparable to supervised rehabilitation in the midterm period requires further research, as practices after TKA vary. The purpose of this study is to compare the effectiveness of supervised and home-based progressive resistance training (PRT) in the midterm postoperative period in female patients undergoing TKA.

Detailed Description

The objective of this study is to compare the pain, quadriceps strength, knee function, joint awareness, and quality of life between supervised or home-based PRT at 3 months after the total knee arthroplasty. The study design is a single-blinded randomized trial. Both groups received standard physiotherapy for three months. In the third month postoperatively, supervised and home-based PRE, which consisted of sixteen sessions of exercise lasting eight weeks initiated. The clinical outcomes were compared at baseline (third month postoperatively) and the fifth month postoperative. The clinical outcomes consisted of pain, range of motion (ROM), quadriceps and hip abductor muscle strength, and WOMAC (Western Ontario and McMaster University Arthritis Index ) score. The performance-based activity limitation test consisted of the 30-second sit-to-stand test, the 40-meter fast-paced walk test and the 9-step stair climb test. Joint awareness was assessed with Forgotten Joint Score-12 (FJS12). The quality of life was evaluated with the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF).

Registry
clinicaltrials.gov
Start Date
July 16, 2019
End Date
June 25, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

UMMUHAN BAS ASLAN

Professor

Pamukkale University

Eligibility Criteria

Inclusion Criteria

  • being a woman between the ages of 50-70
  • underwent unilateral primary TKA surgery due to knee osteoarthritis three months ago
  • understanding verbal and written instructions

Exclusion Criteria

  • revision TKA surgery
  • neurological disease
  • rheumatoid arthritis
  • psychiatric problems
  • severe limitation of knee ROM (knee flexion range \< 90°)
  • regular hypnotic or anxiolytics usage
  • dementia.

Outcomes

Primary Outcomes

40m fast-paced walk test

Time Frame: 8 weeks

The 40m fast-paced walking test measures short-distance walking activities. 40m fast-paced walk test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

Knee range of motion (ROM)

Time Frame: 8 weeks

The universal goniometer was used to measure active knee flexion and extension while the participants were sitting with their knees hanging down on the edge of a firm bed. Knee ROM was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

Quadriceps and hip abductor muscles strength

Time Frame: 8 weeks

The muscle strength was assessed with a hand-held dynamometer. For the quadriceps muscle test, the patient was seated on the edge of a hard bed. The dynamometer was placed on the midline of the tibia 5 cm proximal to the lateral malleolus. The patient was asked to force his leg into extension by overcoming the resistance of the dynamometer. For measurement of hip abductors muscle strength, the patient was placed supine and the dynamometer was placed on the lateral side of the leg, 5 cm proximal to the lateral malleolus. The patient was asked to force his leg into extension by overcoming the resistance of the dynamometer. The quadriceps and hip abductor muscles' strength were assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

30s sit-to-stand test

Time Frame: 8 weeks

The total number of sit-to-stand repetitions completed in 30 seconds was recorded. 30s sit-to-stand test is a measurement of lower limb strength and endurance. 30s sit-to-stand test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

Stair climbing test

Time Frame: 8 weeks

Functional limitations specific to ascending stairs were assessed with timed stair climbing and descending using a standard 9 steps (16-20 cm). Participants were instructed to climb stairs safely as soon as possible. Stair climbing test was assessed at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

Knee pain: Visual Analogy Scale (VAS)

Time Frame: 8 weeks

Knee pain intensity during rest and activity (walking, sitting-to-standing, climbing stairs) were measured using separate 10 cm pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain. Knee pain was evaluated at baseline (third month postoperatively) and after an 8-week intervention (fifth month postoperatively).

Secondary Outcomes

  • Fortgotten Joint Score-12 (FJS-12)(8 weeks)
  • World Health Organization Quality of Life Instrument Short Form (WHOQOL-BREF)(8 weeks)
  • The Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(8 weeks)

Study Sites (1)

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